The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.

oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization

Placebo Comparator: B

"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months.

Drug: clopidogrel

oral, 75 mg daily for 6 months starting on day of randomization

Drug: placebo

oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization

Placebo Comparator: C

Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months.

Drug: clopidogrel

oral, 75 mg daily for 6 months starting on day of randomization

Drug: placebo

oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males or females aged 18 years or older.

2. Patients undergoing coronary angiography and possible PCI with planned use of at least one drug-eluting stent (DES), and without planned use of glycoprotein IIb/IIIa inhibitors. One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting, as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated for all lesions (DES + BMS + non stent).

Have the ability to understand the requirements of the study, including consent for use and disclosure of research-related health information.

Have the ability to comply with study procedures and protocol, including required study visits.

6. A female patient is eligible to enter the study if she is (1) of child-bearing potential and not pregnant or nursing; (2) not of child-bearing potential (i.e., has had a hysterectomy, have both ovaries removed, has tubal ligation, or are post-menopausal, defined as 24 months without menses).

Exclusion Criteria: Pre-PCI

PCI within previous 30 days.

Prior consent to participate in GRAVITAS and not randomized by IVRS.

History of gastro-intestinal bleeding within 6 months.

Major non-cardiac surgery within 6 weeks.

Ischemic stroke within 6 weeks.

Any history of hemorrhagic stroke or sub-arachnoid hemorrhage.

Other bleeding diathesis, or considered by investigator to be at high-risk for bleeding on long-term clopidogrel therapy.

Minor surgical procedures that require cessation of dual anti platelet therapy and result in significant bleeding are NOT eligible.

Current or planned therapy with coumadin anticoagulation.

Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel, ticlopidine), or the non-thienopyridine ticagrelor.

Administration of any GPIIb/IIIa during PCI procedure or prior to initial hospital discharge.

Failure to meet clopidogrel requirements

Major complication during or after PCI

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645918